Noxafil

Noxafil is a prescription medication used to prevent and treat fungal infections caused by Aspergillus or Candida. Noxafil belongs to a group of drugs called triazole antifungal agents, which work by slowing the growth of fungi.

This medication is available as an oral suspension (liquid) and in a delayed-release tablet form. The delayed-release tablets should be swallowed whole and taken with food. Shake Noxafil oral suspension well before use and take during, or within 20 minutes of a meal.

Noxafil is also available as an injection to be given directly into a vein by a healthcare provider.

Common side effects include fever, nausea, and diarrhea.

Noxafil delayed-release tablets, Noxafil injection, and Noxafil oral suspension are prescription medicines used to help prevent and treat fungal infections that can spread throughout your body (invasive fungal infections). These infections are caused by fungi called Aspergillus or Candida. Noxafil is used in people who have an increased chance of getting these infections due to a weak immune system. These include people who have:

• had a hematopoietic stem cell transplantation (bone marrow transplant) with graft versus host disease
• a low white blood cell count due to chemotherapy for blood cancers (hematologic malignancy)

Noxafil oral suspension is also used to treat severe yeast infections of the mouth and throat caused by Candida called oropharyngeal candidiasis (OPC). Noxafil oral suspension can be used as the first treatment for OPC, or as another treatment for OPC after itraconazole or fluconazole treatment has not worked.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Merck Sharp & Dohme Corp.

Serious side effects have been reported. See "Drug Precautions" section.

The most common side effects of Noxafil delayed-release tablets include:

• diarrhea
• fever
• nausea

The most common side effects of Noxafil oral suspension include:

• diarrhea
• nausea
• headache
• vomiting
• fever

The most common side effects of Noxafil injection  include:

• anemia
• abdominal pain
• diarrhea
• nausea
• vomiting

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Noxafil. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your healthcare provider about all of the medications you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Do not take Noxafil if you are taking any of the following medicines:

• sirolimus
• pimozide
• quinidine
• certain statin medicines that lower cholesterol (atorvastatin, lovastatin, simvastatin)
• ergot alkaloids (ergotamine, dihydroergotamine

​Also, you should tell your healthcare provider if you:

• are taking certain medicines that lower your immune system like cyclosporine or tacrolimus
• are taking certain drugs for HIV infection, such as ritonavir, atazanavir, efavirenz, or fosamprenavir. Efavirenz and fosamprenavir can cause a decrease in the Noxafil levels in your body. Efavirenz and fosamprenavir should not be taken with Noxafil.
• are taking midazolam, a hypnotic and sedative medicine

Ask your healthcare provider or pharmacist if you are not sure if you are taking any of these medicines.

Do not start taking a new medicine without talking to your healthcare provider or pharmacist.

Noxafil may cause serious side effects, including:

• drug interactions with cyclosporine or tacrolimus. If you take Noxafil with cyclosporine or tacrolimus, your blood levels of cyclosporine or tacrolimus may increase. Serious side effects can happen in your kidney or brain if you have high levels of cyclosporine or tacrolimus in your blood. Your healthcare provider should do blood tests to check your levels of cyclosporine or tacrolimus if you are taking these medicines while taking Noxafil. Tell your healthcare provider right away if you have swelling in your arm or leg or shortness of breath.
• problems with the electrical system of your heart (arrhythmias and QTc prolongation). Certain medicines used to treat fungus called azoles, including Noxafil, the active ingredient in Noxafil, may cause heart rhythm problems. People who have certain heart problems or who take certain medicines have a higher chance for this problem. Tell your healthcare provider right away if your heartbeat becomes fast or irregular.
• liver problems. Some people who also have other serious medical problems may have severe liver problems that may lead to death, especially if you take certain doses of Noxafil. Your healthcare provider should do blood tests to check your liver while you are taking Noxafil. Call your healthcare provider right away if you have any of the following symptoms of liver problems:
  • itchy skin
  • nausea or vomiting
  • yellowing of your eyes
  • feeling very tired
  • flu-like symptoms
• increased amounts of midazolam in your blood. If you take Noxafil with midazolam, Noxafil increases the amount of midazolam in your blood. This can make your sleepiness last longer. Your healthcare provider should check you closely for side effects if you take midazolam with Noxafil.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Noxafil, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take Noxafil, tell your healthcare provider if you:

• are taking certain medicines that lower your immune system like cyclosporine or tacrolimus.
• are taking certain drugs for HIV infection, such as ritonavir, atazanavir, efavirenz, or fosamprenavir. Efavirenz and fosamprenavir can cause a decrease in the Noxafil levels in your body. Efavirenz and fosamprenavir should not be taken with Noxafil.
• are taking midazolam, a hypnotic and sedative medicine.
• have or had liver problems.
• have or had kidney problems.
• have or had an abnormal heart rate or rhythm, heart problems, or blood circulation problems.
• are pregnant or plan to become pregnant. It is not known if Noxafil will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Noxafil passes into your breast milk. You and your healthcare provider should decide if you will take Noxafil or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. The FDA categorizes medications based on safety for use during pregnancy.

Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy. 

Noxafil falls into category C. There are no well-controlled studies in pregnant women. Noxafil should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby

Do not breastfeed while being treated with Noxafil, unless specifically advised by your doctor.

• Take Noxafil exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much Noxafil to take and when to take it.
• Take Noxafil for as long as your healthcare provider tells you to take it.
• If you take too much Noxafil, call your healthcare provider or go to the nearest hospital emergency room right away.

Noxafil delayed-release tablets:

• Take Noxafil delayed-release tablets with food.
• Take Noxafil delayed-release tablets whole. Do not break, crush, dissolve or chew Noxafil delayed-release tablets before swallowing. If you cannot swallow Noxafil delayed-release tablets whole, tell your healthcare provider. You may need a different medicine.
• If you miss a dose, take it as soon as you remember and then take your next scheduled dose at its regular time. If, however, it is within 12 hours of your next dose, do not take the missed dose. Skip the missed dose and go back to your regular schedule. Do not double your next dose or take more than your prescribed dose.

Noxafil oral suspension:

• Shake Noxafil oral suspension well before use.
• Take each dose of Noxafil oral suspension during or within 20 minutes after a full meal. If you cannot eat a full meal, take each dose of Noxafil oral suspension with a liquid nutritional supplement or an acidic carbonated beverage, like ginger ale.
• A measured dosing spoon comes with your Noxafil oral suspension and is marked for doses of 2.5 mL and 5 mL.
• Rinse the spoon with water after each dose of Noxafil oral suspension and before you store it away.

Noxafil is also available as an injection to be given directly into a vein by a healthcare provider.

Take Noxafil exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

• For prevention of fungal infections: the recommended dose is 200 mg (5 mL) three times a day of the oral suspension. Duration of therapy depends on speed of recovery of certain white blood cells (your neutrophil count) and how weak your immune system is (immunosuppression).

• For treating oropharyngeal candidiasis: the recommended dose is to start with 100 mg (2.5 mL) twice a day of the oral suspension or 300 mg of the injection on the first day, then 100 mg (2.5 mL) of the oral suspension or 300 mg of the injection once a day for 13 days.

• For treating oropharyngeal candidiasis that is not cured by itraconazole or fluconazole: the recommended dose is 400 mg (10 mL) twice a day of the oral suspension. Duration of therapy should be based on the severity of the patient's underlying disease and response to this medication.

If you take too much Noxafil, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Noxafil is administered by a healthcare provider, an overdose is unlikely, but you should still seek emergency care if you suspect an overdose.

• Store Noxafil delayed release tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Noxafil delayed-release tablets in a tightly closed container.
• Do not freeze Noxafil oral suspension.
• Noxafil injection can be stored up to 24 hours refrigerated.
• Safely throw away medicine that is out of date or no longer needed.

Keep this and all medicines out of the reach of children.